510(k) · Cleared
ClearedMatreneu Percutaneous Balloon Compression Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Shineyard Medical Device Co., Ltd. · HAO Instrument, Surgical, Non-Powered
Cleared on Sep 7, 2022 as substantially equivalent to K940973 (Cook, Inc., 1995) after a 161-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 7, 2022
- Review
- 161 days
- Class
- Class I
- Product code
- HAO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940973 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK940973 Mullan Ganglion Microcompression SetCook, Inc. · 1995
- This deviceK220920 Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940973 | Mullan Ganglion Microcompression Set | Cook, Inc. | 1995 | — |
| 0 (this device) | K220920 | Matreneu Percutaneous Balloon Compression Kit | Shenzhen Shineyard Medical Device Co., Ltd. | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HAO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K940973 | Mullan Ganglion Microcompression SetSummary page 4…egulation number 21 CFR § 882.4535 Regulation class 1 Regulation name Nonpowered neurosurgical instrument 510(k) Number K940973 Product Code HAO Manufacturer COOK Incorporated… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HAO devicesHAO Instrument, Surgical, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HAO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HAO
Too few HAO 510(k)s in any year since 2007 to give a median.
Recalls per year · HAO
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAO
8in 2025
MAUDE reports naming product code HAO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 15 |
| 2010 | 0 | — | 1 | 30 |
| 2011 | 0 | — | 1 | 6 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 67 |
| 2016 | 0 | — | 0 | 55 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Matreneu Percutaneous Balloon Compression Kit is intended to be used to the Percutaneous Balloon Compression (PBC) procedure for primary trigeminal neuralgia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220920: Matreneu Percutaneous Balloon Compression Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220920
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026